The invention relates generally to catheters, and more particularly to catheters including authorization systems that enable the catheters to be specifically authorized for use with a hemodynamic (HEMO), electrophysiological (EP) or other recording or mapping device or system to which the catheters are connected during studies or monitoring of patients.
Catheters are used in an increasing number of medical procedures to evaluate various conditions of the patient with which the catheter is utilized. As a result, there are many different configurations of catheters that are constructed for use in the procedures.
While many different configurations of catheters can be utilized for a particular procedure, the exact configuration of the catheter in use must be authorized by the recording or mapping device to which the catheter is connected in order for the device to correctly receive or transmit signals in the procedure using the selected catheter. This is due in large part to the nature of the signals being obtained by the catheter and transmitted to the HEMO/EP system/computer system/computing device, as the catheter necessarily needs to be properly associated or authorized for use not only to obtain the desired signals but to transmit the signals to the computer in a usable manner.
Currently, catheter and device manufacturers, increasingly want to associate proprietary algorithms and methods including those algorithms to their clinical devices to add value and differentiate from the competition. One way currently employed to do this is to digitize the signals at the catheter and to stream the digitized data into a standard digital interface on the HEMO/EP system or computer, such as through universal serial bus (USB) port on the HEMO/EP system. However, this creates problems when the device data needs to be referenced or recorded with other common signals acquired by the same HEMO/EP system and/or computer host, but through a separate and distinct digitization system than is stored and utilized on the catheter. More particularly, in this situation it is often the case that the signals from the catheter and from the other device connected to the computer are not recorded in synchronicity and thus their respective time domains are out of phase with one another. As a result, any events in the recorded signal(s) may not appear, appear time shifted, or only partially appear as a result of the time domain errors when displaying, or using the data to correlate precise events. Worse, if any algorithm utilized within the computing device/computer/EP/HEMO system requires data from outside of its own digitization domain then the phase error between the two digitization systems becomes compounded with the signal processing. This can produce significant variance in results, or in extreme cases error in the end result depending on the complexity of the algorithm(s) utilized in the signal processing and dependencies on the associated data being processed.
If signal digitization algorithms are instead present or loaded on the HEMO/EP system/computer system, and the incoming signals from the catheters are digitized through existing standard interfaces on the HEMO/EP/computer system, there is nothing in the computer system that will prevent reuse or misuse of these proprietary algorithms by end users. For example, in this system configuration virtually any competitive catheter/device technology can be interfaced with and utilize the digitization algorithms loaded onto the system. Thus, a competitor may design a catheter system that utilizes these embedded algorithms without having to independently develop suitable algorithms thereby benefitting from the computer system developer's intellectual property through the lack of controlled enablement with the developed computer system.
In addition, separate from the development of the catheters themselves, a customer may utilize the catheter with a HEMO/EP/computer system that is not compatible with the catheter, creating a misuse scenario whereby the signals from the catheter are processed with inappropriate algorithms, filtering, and preprocessing in the HEMO/EP/computer device such that the intended use, and expected results breach the original regulatory qualification.
In the prior art, one alternative solution to provide proper association of the catheter to an EP/computer system, one solution has been to require the entry into the EP/computer system of a serial number or other identifying information regarding the catheter. The identifying information can be entered automatically upon connection of the catheter to the system, such as via passive means or active digital identification chips present on or within the catheter, or can be input manually. In doing so, the EP/computer system can reference an internal listing of compatible catheters in order to determine if the catheter should be enabled for use with the EP/computer system. Examples of systems of these types are disclosed in CA Patent Nos. 1,200,852 and 2148714 and US Patent Application Publication No. US 2016/0184025, each of which are expressly incorporated herein by reference for all purposes.
However, with these solutions where the identification information can be entered manually, the system can be circumvented to enable unauthorized catheters to be used with the EP/computer system, and where the system automatically retrieves the identification information from the catheter, the system requires costly internal alterations, including custom hardware to communicate with the internal identification components within the catheter.
Accordingly, it is desirable to develop a system for the association and authorization of a catheter for use with an EP/computer system to which the catheter is connected for use in a medical procedure. The system should allow for authorization of the catheter without the need for digitization of the signal at the catheter in order to enable appropriate signal processing at the EP/computer system automatically on connection of the catheter to the system.